Pulse ablation catheter with pressure monitoring and method of calibration thereof

Abstract

The present application relates to the technical field of electrophysiological catheter, in particular to a pulse ablation catheter with pressure monitoring and a calibration method thereof, the pulse ablation catheter of the present application forms a water droplet-shaped head end structure through flat support arms, integrates a sheet-shaped pressure sensor, can realize the adhesion state monitoring of each support arm, uses the adhesion pressure vector to improve the judgment authenticity and accuracy of the adhesion state of the support arm, at the same time, can realize the accurate modeling of the intracardiac cavity in the three-dimensional mapping system through integrated magnetic positioning, presents the head end structure model and the adhesion state in real time, so that the operator can select the effective adhesion flat electrode to carry out pulse ablation discharge, and realize accurate and effective ablation; the calibration method of the present application realizes the accurate calibration of the water droplet-shaped head end structure, can accurately indicate the pressure adhesion stress area in use, effectively improves the accurate judgment of the operator on the adhesion state of the water droplet-shaped head end structure through the superposition of the pressure adhesion stress area and the pressure vector.

Description

Technical Field

[0001] This invention relates to the field of electrophysiological catheter technology, specifically to a pulse ablation catheter with pressure monitoring and its calibration method. Background Technology

[0002] Catheter ablation is currently an effective means of controlling atrial fibrillation in the treatment of atrial fibrillation. It mainly modifies the atrial matrix by isolating the pulmonary veins or combining it with other methods. Multi-electrode pulsed electric field ablation has the characteristics of selective ablation of damaged tissue, fast speed and non-thermal ablation compared with traditional radiofrequency ablation and cryoablation. It is necessary for the pulsed ablation catheter to be in good contact with the tissue during the operation, which has a positive impact on ensuring the success rate of ablation. Insufficient contact may increase the risk of discontinuity of ablation line and pulmonary vein reconnection.

[0003] Due to the varying morphologies of pulmonary vein orifices, existing multi-electrode pulse ablation catheters, including those in the ring, petal, basket, and balloon shapes, may experience instances where some electrodes fail to adhere to the tissue, leading to ineffective ablation and misleading the operator's assessment of ablation continuity and effectiveness. While some existing pulse ablation catheters assess adhesion by measuring the contact impedance between the electrode and tissue, factors such as myocardial tissue, spinal tissue, blood flow, and electrode size can all affect the contact impedance, resulting in inaccurate assessment of adhesion and still causing problems with poor adhesion accuracy. Summary of the Invention

[0004] The purpose of this invention is to overcome the shortcomings of existing pulse ablation catheters in the prior art, which make it difficult to accurately determine the contact status and affect the ablation effect, and to provide a pulse ablation catheter with pressure monitoring and its calibration method.

[0005] In a first aspect, the present invention provides a pulsed ablation catheter with pressure monitoring, comprising a teardrop-shaped tip structure, the teardrop-shaped tip structure comprising:

[0006] The support member includes at least three flat support arms, which are teardrop-shaped and converge at the distal end and connect to the end tube at the proximal end. Each support arm is provided with a sheet-like pressure sensor, and at least one support arm is provided with a 5D magnetic sensor.

[0007] An insulating tube is fitted onto the support arm, and at least two flat electrodes are disposed outside the insulating tube.

[0008] The sheet-like pressure sensor is configured to monitor the magnitude of the contact pressure and to display the pressure vector of the support arm contacting the contact area via a three-dimensional mapping system.

[0009] This invention discloses a pulse ablation catheter with pressure monitoring. It features a teardrop-shaped tip structure formed by flat support arms and an integrated sheet-like pressure sensor. This allows for monitoring of the contact status of each support arm, improving the accuracy and reliability of contact status assessment using contact pressure vectors. Simultaneously, by integrating a magnetic sensor, it enables rapid and precise modeling of the cardiac cavity within a three-dimensional mapping system, providing real-time visualization of the tip structure model and contact status. This allows the operator to select the most effectively contacting flat electrode for pulse ablation discharge, achieving precise and effective ablation.

[0010] Preferably, the support arm includes a first hollow section, a first connecting section, a second hollow section, and a second connecting section arranged sequentially from the distal end to the proximal end. The first hollow section and the second hollow section are each provided with a hollow groove. The 5D magnetic sensor is embedded in the first hollow section, and the sheet-like pressure sensor is attached to the inner surface of the second hollow section. One of the flat electrodes is disposed on the outer side of the 5D magnetic sensor, and several flat electrodes are disposed between the sheet-like pressure sensor and the 5D magnetic sensor. The first hollow section provides a mounting position for the 5D magnetic sensor; the second hollow section provides a safe and fixed position for the sheet-like pressure sensor, preventing destructive damage to the sheet-like pressure sensor during use and avoiding direct interference from external forces during attachment, thereby improving the pressure sensing accuracy of the sheet-like pressure sensor.

[0011] Preferably, the width of the first connecting segment is smaller than the widths of the first and second hollow segments, and the width of the second connecting segment is smaller than the width of the second hollow segment. This forms a "string"-shaped support arm, which improves the flexibility of the support arm in conforming to the surrounding environment and meets the size limitations of the sheath channel during clinical interventions for the teardrop-shaped tip structure.

[0012] Preferably, the support member includes three support arms, and the maximum annular size of the teardrop-shaped head structure formed by the three support arms is 8mm-12mm.

[0013] Preferably, the support member comprises six support arms, and the maximum annular dimension of the teardrop-shaped tip structure formed by the six support arms is 25-30 mm. This is to meet the limitation requirements of the sheath channel size during clinical intervention.

[0014] Preferably, the supporting component is an integrally machined structure made of shape memory nickel-titanium alloy sheet, and the thickness of the shape memory nickel-titanium alloy sheet is 0.05mm-0.1mm.

[0015] Preferably, the first hollow section has a width of 0.7mm-0.8mm and a length of 4.2mm-4.4mm, and is provided with a hollow groove with a width of 0.4mm-0.45mm and a length of 3.5mm-4.0mm; the second hollow section has a width of 1.2mm-1.3mm and a length of 4.4mm-4.6mm, and is provided with a hollow groove with a width of 0.95mm-1.05mm and a length of 3.2mm-3.4mm; the first connecting section has a width of 0.4mm-0.5mm, and the second connecting section has a width of 0.5mm-0.6mm.

[0016] Preferably, the sheet-like pressure sensor includes a sheet-like elastomer, on which strain gauges are adhered. The strain gauges are configured to form at least one lateral sensing region and at least one longitudinal sensing region through a wire grid arrangement. This improves the authenticity and accuracy of determining different contact states by using multiple sensing regions in different directions.

[0017] Preferably, a fixing member is welded to the tail end of the support arm, the fixing member extending into and fixing the end tube; a central reference electrode is provided at the end of the end tube, the central reference electrode has an infusion hole, an infusion tube is coaxially arranged in the infusion hole, an insulating member is provided between the central reference electrode and the fixing member, and a 6D magnetic sensor is provided in the end tube. The fixing member is used to fix the support arm on the catheter, improve the resilience of the teardrop-shaped tip structure, and improve the positioning and pressure accuracy of the ablation catheter in clinical applications.

[0018] In a second aspect, the present invention provides a calibration method for a pulse ablation catheter with pressure monitoring, comprising:

[0019] A pressure sensing model is constructed using a pressure calibration-test model. The sheet pressure sensor on each support arm is calibrated according to a preset pressure value and pressure vector relationship. The pressure sensing model includes a single-arm pressure sensing model, an adjacent-arm pressure sensing model, and / or a symmetrical-arm pressure sensing model.

[0020] The calibration of the sheet-like pressure sensor on each support arm includes:

[0021] Couple pressure accuracy and pressure vector;

[0022] The relevant dependent variable data set is acquired and written into the pressure storage module of the ablation catheter;

[0023] Pressure accuracy and pressure vector are tested and evaluated, and catheters that pass the evaluation meet the requirements for clinical use.

[0024] This invention discloses a calibration method for a pulse ablation catheter with pressure monitoring. By establishing pressure sensing models for single arm, adjacent arm, and / or symmetrical arm, and based on the physical characteristics of the teardrop-shaped tip structure, the method achieves coupling of pressure accuracy and pressure vector of the teardrop-shaped tip structure. This overcomes the problem of flexible deformation of the tip structure itself, enabling precise calibration of the teardrop-shaped tip structure. It allows for accurate indication of the pressure contact area during use. By superimposing the pressure vector on the pressure contact area, the method effectively improves the operator's accurate judgment of the contact state of the teardrop-shaped tip structure. Furthermore, the accurate judgment of the contact state enhances the precision and effectiveness of the catheter pulse discharge.

[0025] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0026] 1. This invention provides a pulse ablation catheter with pressure monitoring, which forms a teardrop-shaped head structure through flat support arms and integrates a sheet-like pressure sensor, enabling the monitoring of the contact status of each support arm. The contact pressure vector is used to improve the authenticity and accuracy of the judgment of the contact status of the support arms.

[0027] 2. This invention provides a pulse ablation catheter with pressure monitoring. By integrating a magnetic sensor, it can quickly and accurately model the heart cavity in a three-dimensional mapping system, and present the head structure model and contact status in real time. This allows the operator to select the flat electrode that is effectively contacted for pulse ablation discharge, thus achieving precise and effective ablation.

[0028] 3. This invention provides a calibration method for a pulse ablation catheter with pressure monitoring. By establishing pressure sensing models for single arm, adjacent arm and / or symmetrical arm respectively, and based on the physical characteristics of the teardrop-shaped tip structure, the method achieves the coupling of pressure accuracy and pressure vector of the teardrop-shaped tip structure, overcomes the problem of flexible deformation of the tip structure itself, and achieves accurate calibration of the teardrop-shaped tip structure. Attached Figure Description

[0029] Figure 1 This is a schematic diagram of the teardrop-shaped head structure formed by the three support arms in Example 1.

[0030] Figure 2 This is a schematic diagram of the internal structure of the teardrop-shaped head structure formed by the three support arms in Example 1.

[0031] Figure 3 This is a schematic diagram of the support structure of the three support arms in Example 1.

[0032] Figure 4 This is a schematic diagram of the assembly of the sheet-like pressure sensor in Example 1 on the support components of the three support arms.

[0033] Figure 5This is a schematic diagram of the assembly of the 5D magnetic sensor in the three support arms in Example 1.

[0034] Figure 6 This is a schematic diagram of the teardrop-shaped head structure formed by the six support arms in Example 1.

[0035] Figure 7 This is a schematic diagram of the internal structure of the teardrop-shaped head structure formed by the six support arms in Example 1.

[0036] Figure 8 This is a schematic diagram of the assembly of the sheet-like pressure sensor in Example 1 with the support components of the six support arms.

[0037] Figure 9 This is a schematic diagram of the assembly of the 5D magnetic sensor in Example 1 on the support components of the six support arms.

[0038] Figure 10 This is a schematic diagram of the sheet-like pressure sensor in Example 1. Figure 1 .

[0039] Figure 11 This is a schematic diagram of the sheet-like pressure sensor in Example 1. Figure 2 .

[0040] Figure 12 This is a schematic diagram of a conduit with three supporting arms in a state of force application when one supporting arm is in contact with the conduit.

[0041] Figure 13 This is a schematic diagram of the force applied to a conduit with three supporting arms when adjacent supporting arms are in contact.

[0042] Figure 14 This is a schematic diagram of a conduit with six supporting arms in a state of force application when the supporting arms are in contact with each other.

[0043] Figure 15 This is a schematic diagram of the force state of a conduit with six supporting arms when adjacent supporting arms are in contact.

[0044] Marked in the image:

[0045] 1-Support arm, 11-First hollow section, 12-First connecting section, 13-Second hollow section, 14-Second connecting section, 15-Hollow groove

[0046] 2-End tube body,

[0047] 3-Sheet-shaped pressure sensor, 31-Sheet-shaped elastomer, 32-Strain gauge, 33-Transverse sensing area, 34-Vertical sensing area

[0048] 4-5D magnetic sensor,

[0049] 5-Insulating tube, 6-Flat electrode, 7-Fixing component, 8-Center reference electrode, 9-Injection tube, 10-Insulating component, 20-6D magnetic sensor. Detailed Implementation

[0050] The present invention will now be described in further detail with reference to specific embodiments. However, this should not be construed as limiting the scope of the present invention to the following embodiments; all technologies implemented based on the content of the present invention fall within the scope of the present invention.

[0051] Unless otherwise specified, the terms "upper," "lower," "left," "right," "center," "inner," and "outer," etc., used in the description of specific embodiments of the present invention to indicate orientation or positional relationships, are based on the orientation or positional relationships shown in the accompanying drawings, or the orientation or positional relationship in which the product / equipment / device is usually placed during use. These terms are merely for the purpose of facilitating the description of the present invention or simplifying the description in specific embodiments, and for enabling those skilled in the art to quickly understand the solution, and do not indicate or imply that a particular device / component / element must have a specific orientation, or be constructed and operated in a specific positional relationship. Therefore, they should not be construed as limitations on the present invention.

[0052] Furthermore, the use of terms such as "horizontal," "vertical," "suspended," "parallel," and "coaxial" does not imply that the corresponding device / component / element must be absolutely horizontal, vertical, suspended, parallel, or coaxial. Slight tilt or deviation is permissible, as long as it does not affect the normal function of the relevant component. For example, "horizontal" simply means that its direction is more horizontal relative to "vertical," not that the structure must be perfectly horizontal; a slight tilt is acceptable. "Coaxial" means that two components are arranged as coaxially as possible, allowing them to move coaxially or approximately coaxially when their relative positions change. Alternatively, it can be simplified to mean that the corresponding device / component / element, when arranged in "horizontal," "vertical," "suspended," "parallel," or "coaxial" directions, can have an error / deviation of ±10% relative to the corresponding direction, more preferably within ±8%, more preferably within ±6%, more preferably within ±5%, and more preferably within ±4%. For example, the deviation in the "coaxial" direction is controlled within 0.2-1mm, preferably within 0.2-0.5mm. As long as the corresponding device / component / element is within the error / deviation range, it can still achieve its function in the solution of the present invention.

[0053] Furthermore, the use of terms such as "first," "second," and "third" in terminology is merely for distinguishing descriptions of identical or similar components and should not be interpreted as emphasizing or implying the relative importance of a particular component.

[0054] Furthermore, in the description of the embodiments of the present invention, "several", "more than", and "a number of" represent at least two. The number can be any number, such as two, three, four, five, six, seven, eight, or nine, and can even exceed nine.

[0055] Furthermore, in the description of the technical solution of this invention, unless otherwise explicitly specified / limited / restricted, the terms "set up," "install," "connect," "link," "provided with," "laid out," and "arranged" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to connection methods commonly used in the art, such as welding, riveting, bolting, and threaded connections. Such connections can be mechanical, electrical, or communication connections; they can be direct connections or indirect connections through an intermediate medium; and they can refer to the internal communication between two components.

[0056] Example 1

[0057] like Figures 1-11 As shown, a pulse ablation catheter with pressure monitoring in this embodiment includes a support member, an insulating tube 5, a sheet-like pressure sensor 3, a 5D magnetic sensor 4, and at least two flat electrodes 6. The support member includes at least three flat support arms 1. Each support arm 1 has a first hollow section 11, a first connecting section 12, a second hollow section 13, and a second connecting section 14 arranged sequentially from the distal end to the proximal end. The first hollow section 11 and the second hollow section 13 are respectively provided with hollow grooves 15. The sheet-like pressure sensor 3 is attached to the second hollow section 13. The 5D magnetic sensor 4 is embedded in the first hollow section 11 of at least one support arm 1. The sheet-like pressure sensor 3 is attached to the inner side of the second hollow section 13 of each support arm 1. The insulating tube 5 is fitted on the support arm 1. One of the flat electrodes 6 is located outside the 5D magnetic sensor 4. Several flat electrodes 6 are located between the sheet-like pressure sensor 3 and the 5D magnetic sensor 4. The at least three flat support arms 1 converge in a teardrop shape at the distal end and connect to the end tube 2 at the proximal end to form a teardrop-shaped head structure.

[0058] This embodiment of a pulse ablation catheter with pressure monitoring comprises a teardrop-shaped tip structure formed by multiple flat support arms 1. A flat, sheet-like pressure sensor 3 and a flattened electrode 6 are integrated on the support arms 1, which improves the contact force stability of the formed teardrop-shaped tip structure. The sheet-like pressure sensor 3 is positioned in the second hollow section 13 of the support arm 1, such as... Figure 3 As shown, located in the main contact deformation support force area of ​​support arm 1, it can effectively capture the strain generated by each support arm 1 during the contact force process, and then calculate and output the contact pressure of the corresponding support arm 1 through the associated pressure module to achieve accurate pressure monitoring.

[0059] In one or more embodiments, the sheet pressure sensor 3 is made of a sheet elastomer 31 and a strain gauge 32 attached to the sheet elastomer 31. The strain gauge 32 is configured to include at least one lateral sensing region 33 and at least one longitudinal sensing region 34, so that the sheet pressure sensor 3 can monitor the magnitude of the contact pressure and can display the pressure vector of the support arm 1 contacting the contact through a three-dimensional mapping system.

[0060] In an optional embodiment, the strain gauge 32 is configured to form three sensing areas through a wire grid layout. The three sensing areas can be arranged in a "horizontal-vertical-horizontal" or "vertical-horizontal-vertical" manner. This not only enables the monitoring of the pressure magnitude of the teardrop-shaped head structure, but also displays the vector direction of the pressure of each support arm 1 through a three-dimensional mapping system. This allows the pressure vector direction of a single support arm 1 to be divided into three contact states: forward, central, and backward. The contact state with the pressure vector of a single support arm 1 in the central position is set as the effective pulse discharge contact state during clinical ablation, thereby improving the authenticity and accuracy of the judgment of different contact states.

[0061] In optional implementations, such as Figure 10 As shown, the wire grid of the strain gauge 32 is arranged in a "horizontal-vertical-horizontal" structure from top to bottom, corresponding to the horizontal sensing area 33, the vertical sensing area 34, and the horizontal sensing area 35, respectively.

[0062] In optional implementations, such as Figure 11 As shown, the wire grid of the strain gauge 32 is arranged in a "vertical-horizontal-vertical" structure from top to bottom, corresponding to the longitudinal sensing area 34, the lateral sensing area 33, and the longitudinal sensing area 34, respectively.

[0063] In one or more embodiments, the width of the first connecting segment 12 is smaller than the width of the first hollow segment 11 and the second hollow segment 13, and the width of the second connecting segment 14 is smaller than the width of the second hollow segment 13, forming a hollow "string"-shaped support arm 1, which can improve the flexibility of the formed teardrop-shaped head structure under contact force deformation, and meet the limitation requirements of the sheath channel size of the teardrop-shaped head structure in clinical intervention.

[0064] In optional implementations, such as Figure 4 , Figure 8As shown, the sheet pressure sensor 3 can be attached to the inner side of the second hollow section 13 near the teardrop-shaped head structure. The sheet pressure sensor 3 overlaps the outer contour of the corresponding hollow groove 15. The outer contour of the second hollow section 13 provides a welding and fixing area for the sheet pressure sensor 3, realizing the stable setting of the sheet pressure sensor 3. At the same time, the outer contour of the hollow groove 15 creates a safety space for the strain gauge 32 on the sheet pressure sensor 3, protecting the strain gauge 32 from destructive damage. It can prevent the strain gauge 32 from being directly interfered with by external forces during the attachment process, effectively improving the pressure sensing accuracy of the sheet pressure sensor 3.

[0065] In an optional embodiment, the hollow groove 15 provided in the second hollow section 13 is a combination of a rectangular groove and a bottom partial notch groove, and the left and right positions of the notch groove provide a welding and fixing area for the sheet pressure sensor 3.

[0066] In optional implementations, such as Figure 5 , Figure 9 As shown, the 5D magnetic sensor 4 can be bonded and fixed inside the hollow groove 15 of the first hollow section 11.

[0067] In an optional embodiment, the supporting component is a structural component integrally machined from a shape memory nickel-titanium alloy sheet.

[0068] In an optional embodiment, the support member is configured as a ring at the distal end, and multiple support arms 1 are evenly distributed radially along the ring. Through the arc transition between the first hollow section 11 and the first connecting section 12, and between the first connecting section 12 and the second hollow section 13, they converge at the proximal end to form a teardrop-shaped structure. The support arms 1 correspond to the sidewalls of the teardrop, the convergence part of the support arms 1 at the proximal end corresponds to the tip of the teardrop, and the ring-shaped structure of the support arms 1 at the distal end and the support arms 1 correspond to the arc-shaped part of the teardrop.

[0069] In an optional embodiment, the thickness of the shape memory nickel-titanium alloy sheet is 0.05mm-0.1mm.

[0070] In an optional embodiment, the first hollow section 11 has a width of 0.7mm-0.8mm and a length of 4.2mm-4.4mm, and is provided with a hollow groove 15 with a width of 0.4mm-0.45mm and a length of 3.5mm-4.0mm; the second hollow section 13 has a width of 1.2mm-1.3mm and a length of 4.4mm-4.6mm, and is provided with a hollow groove 15 with a width of 0.95mm-1.05mm and a length of 3.2mm-3.4mm; the first connecting section 12 has a width of 0.4mm-0.5mm, and the second connecting section 14 has a width of 0.5mm-0.6mm.

[0071] In one or more embodiments, the tail end of the support arm 1 can be connected to a fastener 7 made of metal material that conforms to the application scenario by precision resistance welding or precision laser welding.

[0072] In optional implementations, such as Figure 2 , Figure 7 As shown, the fixing member 7 may include a flat ring assembly that can be fitted onto the tail of the support arm 1 and an extension connected to the end of the ring assembly. The extension is set at an angle to the ring assembly and can extend into the end tube 2 along the axis of the end tube 2 and be bonded to the end tube 2. Thus, the structure of the fixing member 7 can improve the resilience of the teardrop-shaped tip structure and improve the positioning accuracy and pressure accuracy of the catheter in clinical applications.

[0073] In an optional embodiment, a central reference electrode 8 may be provided at the end of the end tube 2. The central reference electrode 8 is provided with an injection hole. An injection tube 9 is coaxially bonded to the injection hole. An insulating member 10 is provided between the central reference electrode 8 and the fixing member 7. The insulating member 10 is bonded and fixed to the central reference electrode 8 and the fixing member 7 respectively.

[0074] In optional implementations, such as Figure 2 , Figure 7 As shown, the insulating component 10 can be a tubular structure with a limiting component at one end, so that the insulating component 10 can be stably installed at the end of the end tube 2, thereby separating the central reference electrode 8 and the fixing component 7.

[0075] In an optional embodiment, the central reference electrode 8 and the flat electrode 6 can be made of medical metal materials such as platinum, iridium, or stainless steel.

[0076] In an optional embodiment, a 6D magnetic sensor 20 can also be installed inside the end tube 2. This allows for the construction of a real-time dynamic model of the teardrop-shaped tip structure by combining the sheet-like pressure sensor 3, the 5D magnetic sensor 4, and the 6D magnetic sensor 20. This enables accurate indication of the pressure contact area, effectively improving the surgeon's accurate judgment of the contact state. Furthermore, by adjusting the contact state, the accuracy and effectiveness of pulsed discharge can be improved.

[0077] In this embodiment, a pulse ablation catheter with pressure monitoring is preferably provided with three or six support arms 1.

[0078] like Figure 1 As shown, the teardrop-shaped head end structure is formed by three support arms 1. The maximum annular size of the teardrop-shaped head end structure is 8mm-12mm, preferably 10mm. Two flat electrodes 6 are arranged on the insulating tube body 5 of the support arm 1, with an electrode spacing of 2-4mm, preferably 3mm. The 5D magnetic sensor 4 is set in the inner cavity section near the installation position of the first flat electrode 6 at the far end, and the sheet pressure sensor 3 is set at the lower end of the other flat electrode 6.

[0079] In an optional implementation, the teardrop-shaped head structure formed by the three support arms 1 can be equipped with 1-3 5D magnetic sensors 4.

[0080] like Figure 6 As shown, the teardrop-shaped head end structure is formed by six support arms 1. The maximum annular size of the teardrop-shaped head end structure is 25mm-30mm, preferably 28mm. Four flat electrodes 6 are arranged on the insulating tube body 5 of the support arm 1, with an electrode spacing of 2-4mm, preferably 3mm. The 5D magnetic sensor 4 is set in the inner cavity section near the installation position of the first flat electrode 6 at the far end. The sheet pressure sensor 3 is set at the lower end of the last flat electrode 6 near the end of the tube body 2.

[0081] In an optional implementation, the teardrop-shaped head structure formed by the six support arms 1 can be equipped with 2-6 5D magnetic sensors 4.

[0082] This embodiment of a pulse ablation catheter with pressure monitoring forms a teardrop-shaped tip structure through a flat support arm 1 and integrates a sheet-like pressure sensor 3. This enables monitoring of the contact status of each support arm 1. By utilizing the contact pressure vector, the accuracy and reliability of the contact status judgment of the support arm 1 are improved. At the same time, by integrating a magnetic sensor, the catheter can quickly and accurately model the intracardiac cavity in a three-dimensional mapping system, presenting the tip structure model and contact status in real time. This allows the operator to select the flat electrode 6 with effective contact for pulse ablation discharge, achieving precise and effective ablation.

[0083] like Figure 12 The diagram shows the contact force state between the catheter with three supporting arms 1 and the inner wall of the pulmonary vein orifice of the heart. This is a single supporting arm 1 contact force state. The contact force vectors are divided into F1, F2, and F3. F1 indicates that the contact area is the first flat electrode 6 near the distal end, suggesting that the second flat electrode 6 may not be effectively in contact with the heart tissue. F2 indicates that the contact area is between the two flat electrodes 6, indicating that both flat electrodes 6 are effectively in contact with the inner wall of the pulmonary vein orifice of the heart. F3 indicates that the contact area is the second flat electrode 6, suggesting that the first flat electrode 6 near the distal end may not be effectively in contact with the heart tissue. The contact force vectors are displayed through a three-dimensional mapping system, which can effectively assist the operator in adjusting the contact state of the teardrop-shaped tip structure to meet the clinical needs for the effectiveness of the flat electrode 6 contact during pulsed ablation discharge.

[0084] like Figure 13As shown, this illustrates the contact and force state between the catheter with three support arms 1 and the inner wall of the pulmonary vein orifice of the heart. This is the contact and force state of adjacent support arms 1. F1' indicates that the contact and force area is closer to the front support arm 1, in which case the ablation flat electrode of the front support arm 1 is preferred for pulse discharge; F2' indicates that the contact and force area includes both the front and rear support arms 1, and the force states of the front and rear support arms 1 are relatively balanced, in which case the ablation flat electrodes of the front and rear support arms 1 can be selected for pulse discharge; F3' indicates that the contact and force area is closer to the rear support arm 1, in which case the ablation flat electrode of the rear support arm 1 is preferred for pulse discharge.

[0085] like Figure 14 The diagram shows the contact force state between the catheter with six supporting arms 1 and the inner wall of the pulmonary vein orifice. In this state, the supporting arms 1 are symmetrically contacted, and the contact force vectors are planar vectors F1, F2, F3 and F1', F2', F3'. Specifically, the flat electrodes 6 are numbered sequentially from distal to proximal. F1 indicates the contact area is between the first flat electrode 6 and the second flat electrode 6. In this case, the preferred pulse ablation discharge electrodes are the first flat electrode 6 and the second flat electrode 6. F2 indicates the contact area is between the second flat electrode 6 and the second flat electrode 6. Between electrode 6 and the third flat electrode 6, the preferred pulse ablation discharge electrodes are the second flat electrode 6 and the third flat electrode 6; F3 indicates that the contact area is between the third flat electrode 6 and the fourth flat electrode 6, and the preferred pulse ablation discharge electrodes are the third flat electrode 6 and the fourth flat electrode 6; the contact force vector is displayed through a three-dimensional mapping system, which can effectively assist the operator in adjusting the contact state of the teardrop-shaped tip structure to meet the clinical needs for the contact effectiveness of the ablation flat electrode during pulse ablation discharge.

[0086] like Figure 15 As shown, this illustrates the contact force state between the catheter of the six support arms 1 and the inner wall of the pulmonary vein orifice of the heart. In this case, adjacent support arms 1 are in contact with each other, and the contact force vectors are planar vectors F1, F2, F3 and spatial vectors F1', F2', F3'. F1' indicates that the contact force area is closer to the front support arm 1, in which case the flat electrode 6 of the front support arm 1 is preferred for pulse discharge. F2' indicates that the contact force area includes both the front and rear support arms 1, and the force states of the front and rear support arms 1 are relatively balanced, in which case the flat electrode 6 of the front and rear support arms 1 can be selected for pulse discharge. F3' indicates that the contact force area is closer to the rear support arm 1, in which case the flat electrode 6 of the rear support arm 1 is preferred for pulse discharge.

[0087] Specifically, when adjacent support arms 1 are in a contact force state, the contact force vector needs to be determined first in the three-dimensional mapping system to determine the spatial vector directionality of the adjacent arms. After the spatial vector directionality is determined, the operator can fine-tune the contact state of the teardrop-shaped head structure according to the information displayed by the three-dimensional mapping system. After adjusting to the expected contact state, the operator can then choose to perform pulse ablation discharge in either the symmetrical support arm contact force state or the adjacent arm contact force state.

[0088] Example 2

[0089] This embodiment is a calibration method for a pulsed ablation catheter with pressure monitoring, as described in Embodiment 1. The method includes: constructing a pressure sensing model using a pressure calibration-test model; calibrating the sheet-like pressure sensor 3 on each support arm 1 according to a preset pressure value and pressure vector relationship; the pressure sensing model includes a single-arm pressure sensing model, an adjacent-arm pressure sensing model, and / or a symmetrical-arm pressure sensing model; the calibration of the sheet-like pressure sensor 3 on each support arm 1 includes: coupling pressure accuracy and pressure vector through the calibration process; writing the relevant strain variable data captured during the calibration process into the pressure storage module of the ablation catheter; and then testing and evaluating the pressure accuracy and pressure vector through the test model to confirm that the catheter's pressure sensing function meets the requirements for clinical application.

[0090] Specifically, the pressure sensing model includes two dimensions: pressure accuracy and pressure vector.

[0091] In an optional implementation, the conduit with three support arms 1 can construct a single-arm pressure sensing model and an adjacent-arm pressure sensing model through a pressure calibration-test model; the conduit with six support arms 1 can construct a single-arm pressure sensing model, an adjacent-arm pressure sensing model, and a symmetrical-arm pressure sensing model through a pressure calibration-test model.

[0092] In an optional implementation, the preset pressure value range can be 10g-70g. Any number of preset pressure values ​​within the range can be selected to form a sequence. Each preset pressure value is combined with the deflection angle and rotation degree to form a data matrix, and calibration is performed according to the sequence in the matrix.

[0093] Specifically, the preset pressure values ​​can be {10g, 20g, 30g, 40g, 50g}, and the corresponding pressure vector relationships can be preset deflection angles of {5°, 30°, 60°, 90°}. The preset rotation angles of the teardrop-shaped head structure of the three support arms 1 can be {0°, 60°, 120°, 180°, 240°, 300°}, and the preset rotation angles of the teardrop-shaped head structure of the six support arms 1 can be {0°, 30°, 60°, 90°, 120°, 150°, 180°, 210°, 240°, 270°, 300°, 330°}.

[0094] Specifically, the preset pressure values ​​can be {15g, 25g, 35g, 45g, 55g}, and the corresponding pressure vector relationships can be preset deflection angles of {10°, 30°, 60°, 90°}. The preset rotation angles of the teardrop-shaped head structure of the three support arms 1 can be {30°, 90°, 150°, 210°, 270°, 330°}, and the preset rotation angles of the teardrop-shaped head structure of the six support arms 1 can be {15°, 45°, 75°, 105°, 135°, 165°, 195°, 225°, 255°, 285°, 315°, 345°}.

[0095] This embodiment presents a calibration method for a pulsed ablation catheter with pressure monitoring. By establishing pressure sensing models for a single arm, adjacent arms, and / or symmetrical arms, and based on the physical characteristics of the teardrop-shaped tip structure, the method couples the pressure accuracy and pressure vector of the teardrop-shaped tip structure, overcoming the inherent flexibility and deformation problem of the tip structure and achieving precise calibration. For catheters that pass the pressure calibration test, a three-dimensional mapping system can display the contact pressure value and pressure vector of the single arm, adjacent arms, and symmetrical arms in real time. The deflection angle indicates the contact pressure vector of the single or symmetrical arm. At this time, the pressure vector is a planar pressure vector (reference). Figure 14 (Solid arrows indicating F1, F2, F3 and F1', F2', F3' are shown in the diagram). Their rotation angles indicate the contact pressure vectors of adjacent arms. At this time, the pressure vectors are spatial pressure vectors, including the spatial pressure vectors between adjacent arms (see reference). Figure 15 (Dashed arrows indicating F1', F2', and F3') and the planar pressure vector of a single arm (see reference). Figure 15 (Solid arrows F1, F2, and F3 are shown in the diagram). The pressure vector can be combined with the real-time dynamic model of the teardrop-shaped tip structure constructed by the 5D magnetic sensor 4 and the 6D magnetic sensor 20 to indicate the pressure contact area. The pressure vector of the micro-sheet pressure sensor 3 is superimposed on the pressure contact area, which can effectively improve the operator's accurate judgment of the contact state of the teardrop-shaped tip structure. By fine-tuning the contact state of the teardrop-shaped tip structure, the accuracy and effectiveness of the pulse discharge of the ablation catheter can be improved.

[0096] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A pulse ablation catheter with pressure monitoring, characterized in that, include: The support member includes at least three flat support arms (1), which are teardrop-shaped and converge at the distal end and connect to the end tube (2) at the proximal end. Each support arm (1) is provided with a sheet pressure sensor (3), and at least one support arm (1) is provided with a 5D magnetic sensor (4). An insulating tube (5) is fitted onto the support arm (1). At least two flat electrodes (6) are provided on the outside of the insulating tube (5). The support arm (1) includes a first hollow section (11), a first connecting section (12), a second hollow section (13), and a second connecting section (14) arranged sequentially from the distal end to the proximal end. The first hollow section (11) and the second hollow section (13) are respectively provided with hollow grooves (15). The 5D magnetic sensor (4) is embedded in the first hollow section (11). The sheet pressure sensor (3) is attached to the inner side of the second hollow section (13). One of the flat electrodes (6) is located on the outside of the 5D magnetic sensor (4). The sheet pressure sensor (3) is configured to monitor the magnitude of the contact pressure and to display the pressure vector of the support arm (1) contacting the support arm (1) through a three-dimensional calibration system. The sheet pressure sensor (3) includes a sheet elastomer (31) on which strain gauges (32) are attached. The strain gauges (32) are configured to form at least one lateral sensing area (33) and at least one longitudinal sensing area (34) through a wire grid layout.

2. The pulse ablation catheter with pressure monitoring according to claim 1, characterized in that, Several of the flat electrodes (6) are disposed between the sheet pressure sensor (3) and the 5D magnetic sensor (4).

3. The pulse ablation catheter with pressure monitoring according to claim 2, characterized in that, The width of the first connecting segment (12) is smaller than the width of the first hollow segment (11) and the second hollow segment (13), and the width of the second connecting segment (14) is smaller than the width of the second hollow segment (13).

4. The pulse ablation catheter with pressure monitoring according to claim 2, characterized in that, The support member includes three support arms (1), and the maximum annular size of the teardrop-shaped head end structure formed by the three support arms (1) is 8mm-12mm.

5. The pulse ablation catheter with pressure monitoring according to claim 2, characterized in that, The support member includes six support arms (1), and the maximum annular size of the teardrop-shaped head end structure formed by the six support arms (1) is 25mm-30mm.

6. The pulse ablation catheter with pressure monitoring according to claim 1, characterized in that, The supporting component is an integrally machined structure made of shape memory nickel-titanium alloy sheet, and the thickness of the shape memory nickel-titanium alloy sheet is 0.05mm-0.1mm.

7. The pulse ablation catheter with pressure monitoring according to claim 2, characterized in that, The first hollow section (11) has a width of 0.7mm-0.8mm and a length of 4.2mm-4.4mm, and is provided with a hollow groove (15) with a width of 0.4mm-0.45mm and a length of 3.5mm-4.0mm; the second hollow section (13) has a width of 1.2mm-1.3mm and a length of 4.4mm-4.6mm, and is provided with a hollow groove (15) with a width of 0.95mm-1.05mm and a length of 3.2mm-3.4mm; the first connecting section (12) has a width of 0.4mm-0.5mm, and the second connecting section (14) has a width of 0.5mm-0.6mm.

8. The pulse ablation catheter with pressure monitoring according to claim 1, characterized in that, The tail end of the support arm (1) is welded with a fixing member (7), which extends into the end tube (2) and is limited and fixed; a center reference electrode (8) is provided at the end of the end tube (2), the center reference electrode (8) is provided with an injection hole, an injection tube (9) is coaxially provided in the injection hole, an insulating member (10) is provided between the center reference electrode (8) and the fixing member (7), and a 6D magnetic sensor (20) is provided in the end tube (2).

9. A calibration method for a pulse ablation catheter with pressure monitoring according to any one of claims 1-8, characterized in that, include: Through the pressure calibration-test model, a pressure sensing model is constructed, and the sheet pressure sensor (3) on each support arm (1) is calibrated according to the preset pressure value and pressure vector relationship. The pressure sensing model includes a single-arm pressure sensing model, an adjacent-arm pressure sensing model and / or a symmetrical-arm pressure sensing model. The calibration of the sheet pressure sensor (3) on each support arm (1) includes: Couple pressure accuracy and pressure vector; The relevant dependent variable data set is acquired and written into the pressure storage module of the ablation catheter; Pressure accuracy and pressure vector are tested and evaluated, and catheters that pass the evaluation meet the requirements for clinical use.

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